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Recruiting NCT07010484

Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica

— Observational Polymyalgia Rheumatica (PMR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PET/MRI, PET/CT with 18-FDG.
Who it may be relevant to
Registry conditions: Polymyalgia Rheumatica (PMR). Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Polymyalgia rheumatica (PMR) is the most common chronic inflammatory rheumatic disease among the elderly and is characterized by proximal extremity pain and fatigue. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to avoid unnecessary treatment. However, clinical diagnosis and even imaging such as positron emission tomography and computed tomography (PET/CT) has low diagnostic accuracy, which decrease after start of prednisolone. The purpose is to evaluate a new method to diagnose PMR with PET/CT using magnetic resonance imaging (MRI) for informing the interpretation of PET in 111 patients suspected of PMR at baseline and after 8 weeks prednisolone treatment. In addition, a treatment initiation strategy guided by clinical diagnosis combined with PET will be evaluated in 100 patients with newly diagnosed PMR.

Interventions

  • Diagnostic test PET/MRI
    PET/MRI at baseline and week 8
  • Diagnostic test PET/CT with 18-FDG
    PET/CT in patients not receiving PET/MRI

Primary outcome measures

  • Clinical diagnosis of PMR after 1 year and a positive baseline [18F]FDG-PET scan, with MRI findings used to support interpretation of the PET evaluation. [Time frame: Baseline]
  • A clinical diagnosis of PMR at baseline and a negative PET not requiring glucocorticoids for more than 3 months during the first year. [Time frame: Baseline to 1 year]
Secondary outcome measures (12)
  • Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline. [Time frame: Baseline]
  • Clinical diagnosis of PMR after 1 year and a positive MRI at baseline. [Time frame: Baseline]
  • Circular, focal, and/or cylindrical [18F]FDG-uptake patterns associated to synovitis, bursitis, and tendinitis/tenosynovitis in the shoulders and hips on MRI or ultrasound. [Time frame: Baseline]
  • Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips. [Time frame: Baseline]
  • Clinical diagnosis of PMR after 1 year and extra-capsular PMR diagnosed using [18F]FDG-PET/MRI. [Time frame: Baseline]
  • Extra-capsular PMR and remission after 2 or 4 weeks. [Time frame: Baseline to 4 weeks]
  • Extra-capsular PMR with relapse and remaining in prednisolone treatment within the first year, first 3 years, and first 5 years. [Time frame: Baseline to 5 years]
  • Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/CT after 8 weeks of prednisolone treatment, with MRI findings used to support PET interpretation. [Time frame: 8 weeks]
  • Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment. [Time frame: 8 weeks]
  • Clinical diagnosis of PMR after 1 year and a positive MRI after 8 weeks of prednisolone treatment. [Time frame: 8 weeks]
  • Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on [18F]FDG-PET/MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years. [Time frame: Baseline to 5 years]
  • Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years. [Time frame: Baseline to 5 years]

Eligibility criteria

Inclusion criteria

  • Patients suspected of PMR seen at the Department of Rheumatology/internal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg.
  • Age above 50.
  • Proximal extremity pain.

Exclusion criteria

  • Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months.
  • Previous prednisolone treatment for GCA/PMR.
  • Unable to give consent.
  • Proximal extremity pain duration for more than one year.
  • Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication).
  • Active malignant cancers within the last 5 years (except basal cell carcinoma).
  • Other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout).
  • Uncontrolled diseases (e.g. severe active asthma, cardiac disease with NYHA class IV)
  • For MRI: Implants contraindicating MRI and BMI>150 kg.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 7 centers
  • Aarhus University Hospital — Aarhus
  • Gødstrup Hospital — Gødstrup
  • Horsens Regional Hospital — Horsens
  • Odense University Hospital — Odense
  • Randers Regional Hospital — Randers
  • Central Jutland Regional Hospital — Silkeborg
  • Svendborg Hospital — Svendborg

Identifiers

NCT: NCT07010484 · 1-10-72-69-25 · NNF24OC0094827

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗